Indications:

NEXGARD kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of paralysis tick infestations in dogs and puppies 8 weeks of age and older, weighing 2kg of body weight or greater, for one month.

Dosage and Administration:

NEXGARD is given orally once a month, at the minimum dosage of 2.5 mg/kg.

Dosing Schedule:

NEXGARD can be administered with or without food. Care should be taken that the dog consumes the complete dose, and treated animals should be observed for a few minutes to ensure that part of the dose is not lost or refused. If it is suspected that any of the dose has been lost or if vomiting occurs within two hours of administration, re-dose with another full dose. If a dose is missed, administer NEXGARD and resume a monthly dosing schedule.

Efficacy:

Paralysis tick, a unique
Australian parasite.

Ixodes holocyclus is present along the east coast of Australia and poses
a serious health risk to dogs. Each year thousands of dogs present to
veterinary hospitals with signs of tick paralysis caused by this parasite.

Two Australian studies were performed to assess the efficacy of
NEXGARDÂ® against this potentially deadly parasite.
In each study, 50 ticks were infested onto each dog on day â€“ 1, 7, 14,
21, 28 and 35.
NEXGARDÂ® was administered on day 0.

Tick counts were conducted on Days 1,2,3 (24, 48 and 72 hours after
administration of NEXGARDÂ®) and thereafter at 24, 48 and 72 hours
post each subsequent tick infestation. In both studies, there was significant mortality of ticks within 24 hours
at all time-points and >98.5% of ticks were killed within 48 hours after
NEXGARDÂ® administration and weekly infestations.

Fleas

NEXGARDÂ® controls fleas within 8 hours of administration. One
controlled study demonstrated 100% mortality of fleas within 6 hours
of administration. NEXGARDÂ® has demonstrated rapid control of fleas
for a full month. NEXGARDÂ® is indicated for the treatment and prevention
of flea infestations and for the control of newly acquired adult fleas.

Two studies have examined the efficacy of NEXGARDÂ® throughout the
month and have demonstrated >95% mortality of fleas within 12 hours
for 3 weeks and >99.9% mortality of fleas within 24 hours for 5 weeks
(following weekly flea infestations).

Important Safety Information:

NexGard is for use in dogs only. The most frequently reported adverse reactions include vomiting, dry/flaky skin, diarrhoea, lethargy, and lack of appetite. The safe use of NexGard in pregnant, breeding or lactating dogs has not been evaluated. Use with caution in dogs with a history of seizures.

Before developing the final formulation of NEXGARDÂ®, numerous studies
were conducted with an experimental oral solution of afoxolaner during which all dogs were evaluated for adverse reactions. The results
of these studies confirmed the potential for afoxolaner as a safe
ectoparasiticide and led the way to additional target animal safety
studies using the final formulation of the product.

A margin of safety study was conducted in healthy puppies as young
as 8 weeks of age. NEXGARDÂ® was administered at approximately
1x, 3x and 5x the exposure dose of 6.3mg/kg for 3 monthly treatments
followed by 3 fortnightly treatments. NEXGARDÂ® was well tolerated
throughout the study period.

A total of six studies were conducted on dogs in Australia confirming the
efficacy and safety of NEXGARDÂ® against fleas and ticks. There were no
treatment related adverse events seen in any of these studies including
in the field trial conducted in real homes across Australia.
Safety data from a large scale US field study involving 415 dogs treated
with NEXGARDÂ® and 200 dogs treated with ComfortisÂ® (spinosad)
showed that the most frequently reported adverse event in both groups
was vomiting, which tended to be self-limiting and of short duration.
The incidence of vomiting was 3x higher in the spinosad-treated group.